01 1Apitoria Pharma Private Limited
02 1Aurobindo Pharma Limited
03 2Hetero Labs Limited
04 1MSN Laboratories Private Limited.
05 1SWATI SPENTOSE PRIVATE LIMITED
06 1Sterling Chemical Malta Ltd.
01 5Dutasteride
02 1Dutasteride "K"
03 1Blank
01 6India
02 1Malta
Dutasteride (for manufacturing purposes only) "Apitoria"
Registration Number : 306MF10087
Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad, Telangana, INDIA.
Initial Date of Registration : 2024-07-03
Latest Date of Registration : 2024-07-03
Registration Number : 231MF10062
Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad Telangana, India
Initial Date of Registration : 2019-03-04
Latest Date of Registration : 2019-03-04
Registration Number : 229MF10186
Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana I...
Initial Date of Registration : 2017-10-12
Latest Date of Registration : 2017-10-12
Registration Number : 231MF10024
Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana I...
Initial Date of Registration : 2019-02-05
Latest Date of Registration : 2019-02-05
Registration Number : 230MF10024
Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, In...
Initial Date of Registration : 2018-02-14
Latest Date of Registration : 2018-02-14
Registration Number : 302MF10123
Registrant's Address : HF51, Hal-Far Industrial Estate BBG3000-Birzebbugia, Malta
Initial Date of Registration : 2020-10-05
Latest Date of Registration : 2020-10-05
Registration Number : 230MF10161
Registrant's Address : 114 Marine Chambers, 11, New Marine Lines, Mumbai-400 020, INDIA
Initial Date of Registration : 2018-12-03
Latest Date of Registration : 2019-11-15
A Dutasteride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dutasteride, including repackagers and relabelers. The FDA regulates Dutasteride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dutasteride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Dutasteride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dutasteride supplier is an individual or a company that provides Dutasteride active pharmaceutical ingredient (API) or Dutasteride finished formulations upon request. The Dutasteride suppliers may include Dutasteride API manufacturers, exporters, distributors and traders.
click here to find a list of Dutasteride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Dutasteride Drug Master File in Japan (Dutasteride JDMF) empowers Dutasteride API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Dutasteride JDMF during the approval evaluation for pharmaceutical products. At the time of Dutasteride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Dutasteride suppliers with JDMF on PharmaCompass.
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